Pressure Sensing Intravascular Devices with Reduced Drift and Associated Systems and Methods

ABSTRACT

Intravascular devices, systems, and methods are disclosed. In some embodiments, the intravascular devices include at least one pressure sensing component positioned within a distal portion of the device. In some instances, a plurality of conductors are electrically coupled to the pressure sensing component and a potting material covers the electrical connections between the plurality of conductors and the pressure sensing component. In some instances, the potting material has a durometer hardness between about 20 Shore A and about 50 Shore A, a moisture absorption rate of about 0% per twenty-four hours, a linear shrinkage of 0%, a coefficient of thermal expansion (m/m/-° C.) of between about 1.0×10 −5  and about 5.0×10 −4 , and a volume resistivity (Ω-cm) between about 6.0×10 13  and about 1.0×10 14 . Methods of making and/or assembling such intravascular devices/systems are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/014,842, filed Aug. 30, 2013, now U.S. Pat. No. ______,which claims priority to and the benefit of U.S. Provisional PatentApplication No. 61/695,955, filed Aug. 31, 2012, both of which arehereby incorporated by reference in their entirety.

TECHNICAL FIELD

The present disclosure relates to intravascular devices, systems, andmethods. In some embodiments, the intravascular devices are pressuresensing guidewires.

BACKGROUND

Heart disease is very serious and often requires emergency operations tosave lives. A main cause of heart disease is the accumulation of plaqueinside the blood vessels, which eventually occludes the blood vessels.Common treatment options available to open up the occluded vesselinclude balloon angioplasty, rotational atherectomy, and intravascularstents. Traditionally, surgeons have relied on X-ray fluoroscopic imagesthat are planar images showing the external shape of the silhouette ofthe lumen of blood vessels to guide treatment. Unfortunately, with X-rayfluoroscopic images, there is a great deal of uncertainty about theexact extent and orientation of the stenosis responsible for theocclusion, making it difficult to find the exact location of thestenosis. In addition, though it is known that restenosis can occur atthe same place, it is difficult to check the condition inside thevessels after surgery with X-ray.

A currently accepted technique for assessing the severity of a stenosisin a blood vessel, including ischemia causing lesions, is fractionalflow reserve (FFR). FFR is a calculation of the ratio of a distalpressure measurement (taken on the distal side of the stenosis) relativeto a proximal pressure measurement (taken on the proximal side of thestenosis). FFR provides an index of stenosis severity that allowsdetermination as to whether the blockage limits blood flow within thevessel to an extent that treatment is required. The normal value of FFRin a healthy vessel is 1.00, while values less than about 0.80 aregenerally deemed significant and require treatment.

Intravascular catheters and guide wires are utilized to measure thepressure within the blood vessel. To date, guidewires containingpressure sensors have suffered from reduced handling characteristicscompared to standard guidewires that do not contain such components.Further, pressure-sensing guide wires have also suffered from reducedprecision and accuracy characteristics with respect to makingintravascular pressure measurements when compared to largerpressure-sensing devices, such as aortic pressure-sensing catheters. Inparticular, to date pressure-sensing guide wires have suffered fromdrift. Drift causes the pressure reading provided by thepressure-sensing guide wire to change (i.e., increase or decrease) overtime as a result of factors associated with the device itself unrelatedto the actual pressure within the vessel. As a result, in order toensure proper FFR calculations, pressure-sensing guide wire must berepeatedly normalized (i.e., relative to an aortic pressure measurementmade by a pressure-sensing catheter) during a procedure. This canincrease the amount of time necessary to perform the procedure, requireadministration of additional pharmaceuticals (e.g., adenosine) to thepatient, or both, which increases the chances for unwanted complicationsduring the procedure.

Accordingly, there remains a need for improved intravascular devices,systems, and methods that include one or more pressure sensingcomponents with no or minimal drift within a guide wire.

SUMMARY

Embodiments of the present disclosure are directed to intravasculardevices, systems, and methods.

In some embodiments, a method of assembling a guidewire is provided. Themethod includes providing a sensor housing having an outer diameter of0.018″ or less, the sensor housing having an inner cavity sized andshaped for receiving a pressure sensor, the inner cavity defined by aninner wall of the sensor housing; positioning a pressure sensor withinthe inner cavity of the housing; electrically coupling a plurality ofconductors to the pressure sensor such that the electrical connectionsbetween the plurality of conductors and the pressure sensor are withinthe inner cavity of the housing; and introducing a potting material intothe inner cavity such that the potting material covers the electricalconnections, wherein the potting material has a durometer hardnessbetween about 20 Shore A and about 50 Shore A.

In some instances, the introduced potting material has a durometerhardness of approximately 25-30 Shore A, a moisture absorption rate ofabout 0% per twenty-four hours, a linear shrinkage of 0%, a coefficientof thermal expansion (m/m/-° C.) of between about 1.0×10⁻⁵ and about5.0×10⁻⁴, and/or a volume resistivity (Ω-cm) between about 6.0×10¹³ andabout 1.0×10¹⁴. Further, the introduced potting material is a UV-curedpotting material with a secondary humidity cure or a secondary heat curein some implementations. Accordingly, in some instances the method alsoincludes curing the potting material with a UV source. Further, in someimplementations electrically coupling the plurality of conductors to thepressure sensor comprises soldering. The method also includes couplingthe sensor housing to a distal portion of a flexible elongate memberhaving an outer diameter of 0.018″ or less in some instances. In someembodiments, the method also includes positioning the plurality ofconductors within a lumen of the flexible elongate member such that theplurality of conductors extend through the lumen from the distal portionof the flexible elongate member to a proximal portion of the flexibleelongate member. Coupling the sensor housing to the distal portion ofthe flexible elongate member includes coupling a proximal portion of thesensor housing to a first flexible element positioned between the distalportion of the flexible elongate member and the proximal portion of thesensor housing in some instances. The method also includes coupling adistal portion of the sensor housing to a second flexible element insome implementations. In that regard, in some instances at least one ofthe first and second flexible elements comprises a coil or a polymertubing.

In some embodiments, a guide wire is provided. The guide wire includes aflexible elongate body having a proximal portion, a distal portion, anda lumen extending along a length of the flexible elongate body betweenthe proximal and distal portions; a pressure sensor coupled to thedistal portion of the flexible elongate body; a plurality of conductorselectrically coupled to the pressure sensor and extending through thelumen of the flexible elongate body to the proximal portion of theflexible elongate body; and a potting material covering electricalconnections between the plurality of conductors and the pressure sensor,wherein the potting material has a durometer hardness between about 20Shore A and about 50 Shore A. In some instances, the potting materialhas a durometer hardness of approximately 25-30 Shore A, a moistureabsorption rate of about 0% per twenty-four hours, a linear shrinkage of0%, a coefficient of thermal expansion (m/m/-° C.) of between about1.0×10⁻⁵ and about 5.0×10⁻⁴, and/or a volume resistivity (Ω-cm) betweenabout 6.0×10¹³ and about 1.0×10¹⁴. Further, the potting material is aUV-cured potting material with a secondary humidity cure or a secondaryheat cure in some implementations.

Additional aspects, features, and advantages of the present disclosurewill become apparent from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present disclosure will be describedwith reference to the accompanying drawings, of which:

FIG. 1 is a diagrammatic, schematic side view of an intravascular deviceaccording to an embodiment of the present disclosure.

FIG. 2 is diagrammatic cross-sectional side view of an intravasculardevice according to an embodiment of the present disclosure.

FIG. 3 is a diagrammatic perspective view of a distal portion of anintravascular device according to an embodiment of the presentdisclosure.

FIG. 4 is a diagrammatic cross-sectional, close up side view of asection of the distal portion of the intravascular device of FIG. 3according to an embodiment of the present disclosure.

FIG. 5 is a diagrammatic cross-sectional, close up perspective view ofthe section of the distal portion of the intravascular device of FIGS. 3and 4.

FIG. 6 is a diagrammatic cross-sectional, side view of inner componentsof the distal portion of the intravascular device of FIG. 3 according toan embodiment of the present disclosure.

FIG. 7 is a graph illustrating average drift characteristics of anintravascular device using a potting material according to an embodimentof the present disclosure compared to average drift characteristics ofan intravascular devices using alternative potting materials indistilled water.

FIG. 8 is a graph illustrating drift characteristics of an intravasculardevice using a potting material according to an embodiment of thepresent disclosure compared to drift characteristics of intravasculardevices using alternative potting materials in saline.

FIG. 9 is a graph illustrating absolute 1-hour drift characteristics ofan intravascular device using a potting material according to anembodiment of the present disclosure compared to absolute 1-hour driftcharacteristics of an intravascular device using an alternative pottingmaterial.

FIG. 10 is a graph illustrating absolute initial offset characteristicsof an intravascular device using a potting material according to anembodiment of the present disclosure compared to absolute initial offsetcharacteristics of an intravascular device using an alternative pottingmaterial.

FIG. 11 is a pair of graphs illustrating the relative driftcharacteristics of an intravascular device using a potting materialaccording to an embodiment of the present disclosure and anintravascular device using an alternative potting material.

FIG. 12 is a graph illustrating a maximum drift of an intravasculardevice using a potting material according to an embodiment of thepresent disclosure compared to a maximum drift of an intravasculardevice using an alternative potting material in a twenty minute animalstudy.

FIG. 13 is a graph illustrating drift characteristics of intravasculardevices using a potting material according to an embodiment of thepresent disclosure compared to drift characteristics of intravasculardevices using an alternative potting material in a twenty minute animalstudy.

FIG. 14 is a graph illustrating drift characteristics of intravasculardevices using a potting material according to an embodiment of thepresent disclosure in a one hour animal study.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It is nevertheless understood that no limitation tothe scope of the disclosure is intended. Any alterations and furthermodifications to the described devices, systems, and methods, and anyfurther application of the principles of the present disclosure arefully contemplated and included within the present disclosure as wouldnormally occur to one skilled in the art to which the disclosurerelates. In particular, it is fully contemplated that the features,components, and/or steps described with respect to one embodiment may becombined with the features, components, and/or steps described withrespect to other embodiments of the present disclosure. For the sake ofbrevity, however, the numerous iterations of these combinations will notbe described separately.

As used herein, “flexible elongate member” or “elongate flexible member”includes at least any thin, long, flexible structure that can beinserted into the vasculature of a patient. While the illustratedembodiments of the “flexible elongate members” of the present disclosurehave a cylindrical profile with a circular cross-sectional profile thatdefines an outer diameter of the flexible elongate member, in otherinstances all or a portion of the flexible elongate members may haveother geometric cross-sectional profiles (e.g., oval, rectangular,square, elliptical, etc.) or non-geometric cross-sectional profiles.Flexible elongate members include, for example, guidewires andcatheters. In that regard, catheters may or may not include a lumenextending along its length for receiving and/or guiding otherinstruments. If the catheter includes a lumen, the lumen may be centeredor offset with respect to the cross-sectional profile of the device.

In most embodiments, the flexible elongate members of the presentdisclosure include at least one pressure sensing component, which may bean electronic, optical, or electro-optical component. Further, in someimplementations the flexible elongate members of the present disclosureinclude an electronic, optical, or electro-optical component in additionto the pressure sensing component. For example, without limitation, aflexible elongate member may include one or more of the following typesof components: a pressure sensor, a temperature sensor, an imagingelement, an optical fiber, an ultrasound transducer, a reflector, amirror, a prism, an ablation element, an RF electrode, a conductor,and/or combinations thereof. Generally, these components are configuredto obtain data related to a vessel or other portion of the anatomy inwhich the flexible elongate member is disposed. Often the components areconfigured to communicate the data to an external device for processingand/or display.

The pressure sensing component(s) and/or other electronic, optical,and/or electro-optical components of the present disclosure are oftendisposed within a distal portion of the flexible elongate member. Asused herein, “distal portion” of the flexible elongate member includesany portion of the flexible elongate member from the mid-point to thedistal tip. As flexible elongate members can be solid, some embodimentsof the present disclosure will include a housing portion at the distalportion for receiving the electronic components. Such housing portionscan be tubular structures attached to the distal portion of the elongatemember. Some flexible elongate members are tubular and have one or morelumens in which the electronic components can be positioned within thedistal portion.

The pressure sensing component(s) and/or other electronic, optical,and/or electro-optical components and the associated communication linesare sized and shaped to allow for the diameter of the flexible elongatemember to be very small. For example, the outside diameter of theelongate member, such as a guidewire or catheter, containing one or moreelectronic, optical, and/or electro-optical components as describedherein are between about 0.0007″ (0.0178 mm) and about 0.118″ (3.0 mm),with some particular embodiments having outer diameters of approximately0.014″ (0.3556 mm) and approximately 0.018″ (0.4572 mm)). As such, theflexible elongate members incorporating the pressure sensingcomponent(s) and/or other electronic, optical, and/or electro-opticalcomponent(s) of the present application are suitable for use in a widevariety of lumens within a human patient besides those that are part orimmediately surround the heart, including veins and arteries of theextremities, renal arteries, blood vessels in and around the brain, andother lumens. Accordingly, in some instances the devices and systems ofthe present disclosure have applications related to organs including theliver, heart, kidneys, gall bladder, pancreas, lungs; ducts; intestines;nervous system structures including the brain, dural sac, spinal cordand peripheral nerves; the urinary tract; as well as valves within theblood or other systems of the body.

“Connected” and variations thereof as used herein includes directconnections, such as being glued or otherwise fastened directly to, on,within, etc. another element, as well as indirect connections where oneor more elements are disposed between the connected elements.

“Secured” and variations thereof as used herein includes methods bywhich an element is directly secured to another element, such as beingglued or otherwise fastened directly to, on, within, etc. anotherelement, as well as indirect techniques of securing two elementstogether where one or more elements are disposed between the securedelements.

Referring now to FIG. 1, shown therein is a portion of an intravasculardevice 100 according to an embodiment of the present disclosure. In thatregard, the intravascular device 100 includes a flexible elongate member102 having a distal portion 104 adjacent a distal end 105 and a proximalportion 106 adjacent a proximal end 107. A component 108 is positionedwithin the distal portion 104 of the flexible elongate member 102proximal of the distal tip 105. Generally, the component 108 isrepresentative of one or more electronic, optical, or electro-opticalcomponents. In that regard, the component 108 is a pressure sensor, atemperature sensor, an imaging element, an optical fiber, an ultrasoundtransducer, a reflector, a mirror, a prism, an ablation element, an RFelectrode, a conductor, and/or combinations thereof. The specific typeof component or combination of components can be selected based on anintended use of the intravascular device. In some instances, thecomponent 108 is positioned less than 10 cm, less than 5, or less than 3cm from the distal tip 105. In some instances, the component 108 ispositioned within a housing of the flexible elongate member 102. In thatregard, the housing is a separate component secured to the flexibleelongate member 102 in some instances. In other instances, the housingis integrally formed as a part of the flexible elongate member 102.

The intravascular device 100 also includes a connector 110 adjacent theproximal portion 106 of the device. In that regard, the connector 110 isspaced from the proximal end 107 of the flexible elongate member 102 bya distance 112. Generally, the distance 112 is between 0% and 50% of thetotal length of the flexible elongate member 102. While the total lengthof the flexible elongate member can be any length, in some embodimentsthe total length is between about 1300 mm and about 4000 mm, with somespecific embodiments have a length of 1400 mm, 1900 mm, and 3000 mm.Accordingly, in some instances the connector 110 is positioned at theproximal end 107. In other instances, the connector 110 is spaced fromthe proximal end 107. For example, in some instances the connector 110is spaced from the proximal end 107 between about 0 mm and about 1400mm. In some specific embodiments, the connector 110 is spaced from theproximal end by a distance of 0 mm, 300 mm, and 1400 mm.

The connector 110 is configured to facilitate communication between theintravascular device 100 and another device. More specifically, in someembodiments the connector 110 is configured to facilitate communicationof data obtained by the component 108 to another device, such as acomputing device or processor. Accordingly, in some embodiments theconnector 110 is an electrical connector. In such instances, theconnector 110 provides an electrical connection to one or moreelectrical conductors that extend along the length of the flexibleelongate member 102 and are electrically coupled to the component 108.In other embodiments, the connector 110 is an optical connector. In suchinstances, the connector 110 provides an optical connection to one ormore optical communication pathways (e.g., fiber optic cable) thatextend along the length of the flexible elongate member 102 and areoptically coupled to the component 108. Further, in some embodiments theconnector 110 provides both electrical and optical connections to bothelectrical conductor(s) and optical communication pathway(s) coupled tothe component 108. In that regard, it should again be noted thatcomponent 108 is comprised of a plurality of elements in some instances.In some instances, the connector 110 is configured to provide a physicalconnection to another device, either directly or indirectly. In otherinstances, the connector 110 is configured to facilitate wirelesscommunication between the intravascular device 100 and another device.Generally, any current or future developed wireless protocol(s) may beutilized. In yet other instances, the connector 110 facilitates bothphysical and wireless connection to another device.

As noted above, in some instances the connector 110 provides aconnection between the component 108 of the intravascular device 100 andan external device. Accordingly, in some embodiments one or moreelectrical conductors, one or more optical pathways, and/or combinationsthereof extend along the length of the flexible elongate member 102between the connector 110 and the component 108 to facilitatecommunication between the connector 110 and the component 108.Generally, any number of electrical conductors, optical pathways, and/orcombinations thereof can extend along the length of the flexibleelongate member 102 between the connector 110 and the component 108. Insome instances, between one and ten electrical conductors and/or opticalpathways extend along the length of the flexible elongate member 102between the connector 110 and the component 108. For the sake of clarityand simplicity, the embodiments of the present disclosure describedbelow include three electrical conductors. However, it is understoodthat the total number of communication pathways and/or the number ofelectrical conductors and/or optical pathways is different in otherembodiments. More specifically, the number of communication pathways andthe number of electrical conductors and optical pathways extending alongthe length of the flexible elongate member 102 is determined by thedesired functionality of the component 108 and the correspondingelements that define component 108 to provide such functionality.

Referring now to FIG. 2, shown therein is a cross-sectional side view ofan intravascular device 200 according to an embodiment of the presentdisclosure. In that regard, the intravascular device 200 is provided asan exemplary embodiment of the type of intravascular device into whichthe potting materials, including the associated methods and structuralarrangements, described below with respect to FIGS. 3-14 can beimplemented. However, it is understood that the no limitation isintended thereby and that the concepts of the present disclosure areapplicable to a wide variety of intravascular devices, including thosedescribed in U.S. Pat. No. 7,967,762 and U.S. Patent ApplicationPublication No. 2009/0088650, each of which is hereby incorporated byreference in its entirety.

As shown in FIG. 2, the intravascular device 200 includes a proximalportion 202, a middle portion 204, and a distal portion 206. Generally,the proximal portion 202 is configured to be positioned outside of apatient, while the distal portion 206 and a majority of the middleportion 204 are configured to be inserted into the patient, includingwithin human vasculature. In that regard, the middle and distal portion204 have an outer diameter between about 0.0007″ (0.0178 mm) and about0.118″ (3.0 mm) in some embodiments, with some particular embodimentshaving an outer diameter of approximately 0.014″ (0.3556 mm) orapproximately 0.018″ (0.4572 mm)). In the illustrated embodiment of FIG.2, the intravascular device 200 has an outer diameter of 0.014″ (0.3556mm).

As shown, the distal portion 206 of the intravascular device 200 has adistal tip 207 defined by an element 208. In the illustrated embodiment,the distal tip 207 has a rounded profile. In some instances, the element208 is radiopaque such that the distal tip 207 is identifiable underx-ray, fluoroscopy, and/or other imaging modalities when positionedwithin a patient. In some particular instances, the element 208 issolder secured to a flexible element 210 and/or a flattened tip core212. In that regard, in some instances the flexible element 210 is acoil spring. The flattened tip core 212 extends distally from a distalportion of a core 214. As shown, the distal core 214 tapers to a narrowprofile as it extends distally towards the distal tip 207. In someinstances, the distal core 214 is formed of a stainless steel that hasbeen ground down to have the desired tapered profile. In some particularinstances, the distal core 214 is formed of high tensile strength 304Vstainless steel. In an alternative embodiment, the distal core 214 isformed by wrapping a stainless steel shaping ribbon around a Nitinolcore and/or extending a stainless steel shaping ribbon alongside (e.g.,parallel to) a Nitinol core. In some embodiments, the distal core 214 issecured to a mounting structure 218 by mechanical interface, solder,adhesive, combinations thereof, and/or other suitable techniques asindicted by reference numerals 216. The mounting structure 218 isconfigured to receive and securely hold a component 220. In that regard,the component 220 is one or more of an electronic component, an opticalcomponent, and/or electro-optical component. For example, withoutlimitation, the component 220 may be one or more of the following typesof components: a pressure sensor, a temperature sensor, an imagingelement, an optical fiber, an ultrasound transducer, a reflector, amirror, a prism, an ablation element, an RF electrode, a conductor,and/or combinations thereof.

The mounting structure 218 is fixedly secured within the distal portion206 of the intravascular device 200. The mounting structure 218 may befixedly secured to a core wire (i.e., a single core running along thelength of the mounting structure), flexible elements or other componentssurrounding at least a portion of the mounting structure (e.g., coils,polymer tubing, etc.), and/or other structure(s) of the intravasculardevice positioned adjacent to the mounting structure. In the illustratedembodiment, the mounting structure is disposed at least partially withinflexible element 210 and/or a flexible element 224 and secured in placeby an adhesive or solder 222. In some instances, the flexible elements210 and 224 are flexible coils. In one particular embodiment, theflexible element 224 is ribbon coil covered with a polymer coating. Forexample, in one embodiment the flexible element 224 is a stainless steelribbon wire coil coated with polyethylene terephthalate (PET). In someimplementations, flexible element 224 acts as a substrate for lubriciouscoating. In that regard, a hydrophilic is utilized in some instances. Inanother embodiment, the flexible element is a polyimide tubing that hasa ribbon wire coil embedded therein. An adhesive is utilized to securethe mounting structure 218 to the flexible element 210 and/or theflexible element 224 in some implementations. Accordingly, in someinstances the adhesive is urethane acrylate, cyanoacrylate, silicone,epoxy, and/or combinations thereof.

In some embodiments, the mounting structure 218 is a housing (See, forexample, device 300 of FIGS. 3-6 described below) configured to receivecomponent 220. In some embodiments, the housing is a generallycylindrical housing having an inner opening or passage for receivingcomponent 220. In that regard, the housing separates the flexibleelements 210 and 224 from one another in some embodiments. Accordingly,in some instances the flexible element 210 is secured to a distalportion of the housing, while the flexible element 224 is secured to aproximal portion of the housing. Further still, in some embodimentsmounting structure 218 is implemented as described in U.S. ProvisionalPatent Application No. 61/695,970 titled “MOUNTING STRUCTURES FORCOMPONENTS OF INTRAVASCULAR DEVICES” and filed on Aug. 31, 2012(Attorney Docket No. 44755.903), which is hereby incorporated byreference in its entirety. Further still, in some embodiments themounting structure 218 is received within a housing. Accordingly, it isunderstood that the application of potting materials in the mannerdescribed below can be utilized in embodiments of intravascular devicesthat include a housing separate from the flexible element(s) andmounting structure, as well as embodiments that do not include a housingseparate from the flexible element(s) and mounting structure.

As shown in FIG. 2, the mounting structure 218 is secured to a core 226that extends proximally from the mounting structure towards the middleportion 204 of the intravascular device 200. In that regard, core 226and distal core 214 are integrally formed in some embodiments such thata continuous core passes through the mounting structure. In otherembodiments, core 226 and distal core 214 are separate elements. In theillustrated embodiment, a portion 228 of the core 226 tapers as itextends distally towards mounting structure 218. However, in otherembodiments the core 226 has a substantially constant profile along itslength. In some implementations, the diameter or outer profile (fornon-circular cross-sectional profiles) of core 226 and core 214 are thesame. In some implementations, a hypotube is utilized in place of core226. Like distal core 214, the core 226 is fixedly secured to themounting structure 218. In some instances, solder and/or adhesive isused to secure the core 226 to the mounting structure 218. In theillustrated embodiment, solder/adhesive 230 surrounds at least a part ofthe portion 228 of the core 226. In some instances, the solder/adhesive230 is the solder/adhesive 222 used to secure the mounting structure 218to the flexible element 210 and/or flexible element 224. In otherinstances, solder/adhesive 230 is a different type of solder or adhesivethan solder/adhesive 222. In one particular embodiment, adhesive orsolder 222 is particularly suited to secure the mounting structure 218to flexible element 210, while solder/adhesive 230 is particularlysuited to secure the mounting structure to flexible element 224.

A communication cable 232 extends along the length of the intravasculardevice 200 from the proximal portion 202 to the distal portion 206. Inthat regard, the distal end of the communication cable 232 is coupled tothe component 220 at junction 234. The type of communication cableutilized is dependent on the type of electronic, optical, and/orelectro-optical components that make up the component 220. In thatregard, the communication cable 232 may include one or more of anelectrical conductor, an optical fiber, and/or combinations thereof.Appropriate connections are utilized at the junction 234 based on thetype of communication lines included within communication cable 232. Forexample, electrical connections are soldered in some instances, whileoptical connections pass through an optical connector in some instances.In some embodiments, the communication cable 232 is a trifilarstructure. Further, it is understood that all and/or portions of each ofthe proximal, middle, and/or distal portions 202, 204, 206 of theintravascular device 200 may have cross-sectional profiles as shown inFIGS. 2-5 of U.S. Provisional Patent Application No. 61/665,697 filed onJun. 28, 2012, which is hereby incorporated by reference in itsentirety.

As will be discussed in greater detail below, the volume of spacesurrounding the junction 234 wherein the communication cable 232 iscoupled to the component 220 (e.g., space within a housing containingcomponent 220, space between the mounting structure 218 and asurrounding flexible element 210, 224, and/or other space) is filledwith a potting material according to some embodiments of the presentdisclosure. In that regard, Applicants have found that the use ofpotting materials having particular material characteristics around thejunction 234 provide an unexpectedly significant reduction and/orelimination of drift in pressure sensing guide wires. In some instances,the potting material is applied to a soldered connection at junction 234prior to the component 220 being installed into the housing or mountingstructure 218. More specifically, in some embodiments the pottingmaterial has a durometer hardness between about 20 Shore A and about 50Shore A, with some particular embodiments having a durometer hardness ofapproximately 25-30 Shore A. Further, the potting material has amoisture absorption rate of about 0% per twenty-four hours in someimplementations. In some instances, the potting material is a UV-curedpotting material. In that regard, in some embodiments, the UV-curedpotting material includes a secondary cure, such as a humidity cure or aheat cure. Further, the potting material has a linear shrinkage of 0% insome instances. In some implementations, the potting material has acoefficient of thermal expansion (m/m/-° C.) of between about 1.0×10⁻⁵and about 5.0×10⁻⁴, with some particular embodiments having acoefficient of thermal expansion (m/m/-° C.) of about 2.89×10⁻⁴. In someembodiments, the potting material has a volume resistivity (Ω-cm)between about 6.0×10¹³ and about 1.0×10¹⁴, with some particularembodiments having a volume resistivity (Ω-cm) of about 8.3×10¹³. Insome implementations, the potting material is Loctite® 5248™. In thatregard, additional information about Loctite® 5248™ is available in theLoctite® 5248™ Technical Data Sheet dated October 2004, which is herebyincorporated by reference in its entirety. Additional details regardingimplementation of potting materials in accordance with the presentdisclosure will be described below with respect to FIGS. 3-14.

Further, in some embodiments, the proximal portion 202 and/or the distalportion 206 incorporate spiral ribbon tubing as disclosed in U.S.Provisional Patent Application No. 61/665,697 filed on Jun. 28, 2012. Insome instances, the use of such spiral ribbon tubing allows a furtherincrease in the available lumen space within the device. For example, insome instances use of a spiral ribbon tubing having a wall thicknessbetween about 0.001″ and about 0.002″ facilitates the use of a core wirehaving an outer diameter of at least 0.0095″ within a 0.014″ outerdiameter guide wire using a trifilar with circular cross-sectionalconductor profiles. The size of the core wire can be further increasedto at least 0.010″ by using a trifilar with the flattened oblongcross-section conductor profiles. The availability to use a core wirehaving an increased diameter allows the use of materials having a lowermodulus of elasticity than a standard stainless steel core wire (e.g.,superelastic materials such as Nitinol or NiTiCo are utilized in someinstances) without adversely affecting the handling performance orstructural integrity of the guide wire and, in many instances, providesimprovement to the handling performance of the guide wire, especiallywhen a superelastic material with an increased core diameter (e.g., acore diameter of 0.0075″ or greater) is utilized within the distalportion 206.

The distal portion 206 of the intravascular device 200 also optionallyincludes at least one imaging marker 236. In that regard, the imagingmarker 236 is configured to be identifiable using an external imagingmodality, such as x-ray, fluoroscopy, angiograph, CT scan, MRI, orotherwise, when the distal portion 206 of the intravascular device 200is positioned within a patient. In the illustrated embodiment, theimaging marker 236 is a radiopaque coil positioned around the tapereddistal portion 228 of the core 226. Visualization of the imaging marker236 during a procedure can give the medical personnel an indication ofthe size of a lesion or region of interest within the patient. To thatend, the imaging marker 236 can have a known length (e.g., 0.5 cm or 1.0cm) and/or be spaced from the element 208 by a known distance (e.g., 3.0cm) such that visualization of the imaging marker 236 and/or the element208 along with the anatomical structure allows a user to estimate thesize or length of a region of interest of the anatomical structure. Itis understood that a plurality of imaging markers 236 are utilized insome instances. In that regard, in some instances the imaging markers236 are spaced a known distance from one another to further facilitatemeasuring the size or length of the region of interest.

In some instances, a proximal portion of the core 226 is secured to acore 238 that extends through the middle portion 204 of theintravascular device. In that regard, the transition between the core226 and the core 238 may occur within the distal portion 206, within themiddle portion 204, and/or at the transition between the distal portion206 and the middle portion 204. For example, in the illustratedembodiment the transition between core 226 and core 238 occurs in thevicinity of a transition between the flexible element 224 and a flexibleelement 240. The flexible element 240 in the illustrated embodiment is ahypotube. In some particular instances, the flexible element is astainless steel hypotube. Further, in the illustrated embodiment aportion of the flexible element 240 is covered with a coating 242. Inthat regard, the coating 242 is a hydrophobic coating in some instances.In some embodiments, the coating 242 is a polytetrafluoroethylene (PTFE)coating.

The proximal portion of core 226 is fixedly secured to the distalportion of core 238. In that regard, any suitable technique for securingthe cores 226, 238 to one another may be used. In some embodiments, atleast one of the cores 226, 238 includes a plunge grind or otherstructural modification that is utilized to couple the cores together.In some instances, the cores 226, 238 are soldered together. In someinstances, an adhesive is utilized to secure the cores 226, 238together. In some embodiments, combinations of structural interfaces,soldering, and/or adhesives are utilized to secure the cores 226, 238together. In other instances, the core 226 is not fixedly secured tocore 238. For example, in some instances, the core 226 and the core 246are fixedly secured to the hypotube 240 and the core 238 is positionedbetween the cores 226 and 246, which maintains the position of the core238 between cores 226 and 246.

In some embodiments, the core 238 is formed of a different material thanthe core 226. For example, in some instances the core 226 is formed ofNitinol and the core 238 is formed of stainless steel. In otherinstances, the core 238 and the core 226 are formed of the samematerial. In some instances the core 238 has a different profile thanthe core 226, such as a larger or smaller diameter and/or a non-circularcross-sectional profile. For example, in some instances the core 238 hasa D-shaped cross-sectional profile. In that regard, a D-shapedcross-sectional profile has some advantages in the context of anintravascular device 200 that includes one or more electronic, optical,or electro-optical component in that it provides a natural space to runany necessary communication cables while providing increased strengththan a full diameter core. In other instances, core 238 and core 226 aremade of the same material and/or have the same structure profiles suchthat the cores 226 and 238 form a continuous, monolithic core.

In some instances, a proximal portion of the core 238 is secured to acore 246 that extends through at least a portion of the proximal portion202 of the intravascular device 200. In that regard, the transitionbetween the core 238 and the core 246 may occur within the proximalportion 202, within the middle portion 204, and/or at the transitionbetween the proximal portion 202 and the middle portion 204. Forexample, in the illustrated embodiment the transition between core 238and core 246 is positioned distal of a plurality of conducting bands248. In that regard, in some instances the conductive bands 248 areportions of a hypotube. Proximal portions of the communication cable 232are coupled to the conductive bands 248. In that regard, in someinstances each of the conductive bands is associated with acorresponding communication line of the communication cable 232. Forexample, in embodiments where the communication cable 232 consists of atrifilar, each of the three conductive bands 248 are connected to one ofthe conductors of the trifilar, for example by soldering each of theconductive bands to the respective conductor. Where the communicationcable 232 includes optical communication line(s), the proximal portion202 of the intravascular device 200 includes an optical connector inaddition to or instead of one or more of the conductive bands 248. Aninsulating layer or sleeve 250 separates the conductive bands 248 fromthe core 246. In some instances, the insulating layer 250 is formed ofpolyimide.

As noted above, the proximal portion of core 238 is fixedly secured tothe distal portion of core 246. In that regard, any suitable techniquefor securing the cores 238, 246 to one another may be used. In someembodiments, at least one of the cores includes a structural featurethat is utilized to couple the cores together. In the illustratedembodiment, the core 238 includes an extension 252 that extends around adistal portion of the core 246. In some instances, the cores 238, 246are soldered together. In some instances, an adhesive is utilized tosecure the cores 238, 246 together. In some embodiments, combinations ofstructural interfaces, soldering, and/or adhesives are utilized tosecure the cores 238, 246 together. In other instances, the core 226 isnot fixedly secured to core 238. For example, in some instances and asnoted above, the core 226 and the core 246 are fixedly secured to thehypotube 240 and the core 238 is positioned between the cores 226 and246, which maintains the position of the core 238 between cores 226 and246. In some embodiments, the core 246 is formed of a different materialthan the core 238. For example, in some instances the core 246 is formedof Nitinol and/or NiTiCo (nickel-titanium-cobalt alloy) and the core 238is formed of stainless steel. In that regard, by utilizing a Nitinolcore within the conductive bands 248 instead of a stainless steel thelikelihood of kinking is greatly reduced because of the increasedflexibility of the Nitinol core compared to a stainless steel core. Inother instances, the core 238 and the core 246 are formed of the samematerial. In some instances the core 238 has a different profile thanthe core 246, such as a larger or smaller diameter and/or a non-circularcross-sectional profile. In other instances, core 238 and core 246 aremade of the same material and/or have the same structure profiles suchthat the cores 238 and 246 form a continuous, monolithic core.

Referring now to FIGS. 3-6, shown therein are aspects of a pressuresensing intravascular device 300 incorporating potting materialsaccording to an embodiment of the present disclosure. In that regard,FIG. 3 illustrates a section of a distal portion of the intravasculardevice 300. As shown, the intravascular device 300 includes a housing302 having an opening 304 that exposes a sensing component 306 to asurrounding environment. In the illustrated embodiment, the housing 302is generally cylindrical in shape with an outer diameter ofapproximately 0.014″ (0.3556 mm). Further, in the illustrated embodimentthe sensing component 306 is a pressure sensor having a diaphragm 308.In that regard, the diaphragm 308 is exposed to the surroundingenvironment or ambient by the opening 304 in the housing such that thediaphragm 308 is responsive to the pressure of the surroundingenvironment/ambient. In that regard, the amount of pressure imparted onthe diaphragm 308 determines the resulting signal generated by thepressure sensing component 306.

The housing 302 is coupled to a proximal flexible element 310 and adistal flexible element 312. In the illustrated embodiment, portions ofthe flexible elements 310 and 312 threaded into corresponding openingsor recesses formed in the housing 302. However, the flexible elements310 and 312 may be connected to the housing using any suitabletechnique. As shown, a communication cable 314 consisting of threeconductors extends proximally from the pressure sensing component 306.Also, as best seen in FIGS. 4 and 5, a core 316 extends proximally fromthe pressure sensing component 306. In some instances, the core 316 alsoextends distally from the pressure sensing component 306. In someembodiments, a portion of the core 316 configured to interface with thepressure sensing component 306 and/or an associated mounting structurehas a reduced profile relative to adjacent portions of the core. Theconductors of the communications cable 314 are electrically coupled tothe pressure sensing component 306. In that regard, in some instancesdistal portions of each of the three conductors are exposed (e.g., byremoving any surrounding insulating layer(s)) and soldered (or otherwiseelectrically coupled) to an electrical connector of the pressure sensingcomponent.

With the communications cable 314 electrically coupled to the pressuresensing component 306 a potting material 320 is introduced over theconnections between the communication cable 314 and the pressure sensingcomponent 306. In that regard, in some instances at least some or all ofthe potting material 320 is positioned over the connections between thecommunication cable 314 and the pressure sensing component 306 prior topositioning those components within the housing 302. In that regard,application of the potting material 320 prior to positioning within thehousing 302 facilitates modular assembly, where the communication cable314 and pressure sensing component 306 can be preassembled and tested asa modular component before being positioned within the housing 302. Thiscan speed up manufacturing and increase yields in some instances. Inother instances, however, the potting material 320 is introduced afterthe pressure sensing component 306 and communication cable 314 arepositioned within the housing 302.

The potting material 320 completely covers all exposed wire, solder, andpad contacts on the pressure sensing component 306. In that regard, insome manufacturing implementations an operator or corresponding machineapplies the potting material 320 onto the trifilar insulation. In someinstances, the pressure sensing component 306 has a split design suchthat the pads are on a surface that is approximately at the midthickness of the sensor and the adhesive is applied to go up to athicker section of the pressure sensing component. Further, the volumeof potting material applied is controlled via an EFD dispenser in someinstances, which provides control over the resulting thickness of thepotting material 320. Based on the specific design parameters of theconnection between the communication cable 314 and the pressure sensingcomponent, minimum and maximum volume limits can be set to define arange of volumes that provide adequate coverage. In that regard, becausethe potting material 320 is applied at the sensor subassembly level insome instances, it can be important that the thickness not be too largesuch that the resulting bulge of potting material may push against othercomponents (e.g., the core wire) once installed into the housing 302. Insome implementations, the potting material 320 has a thickness such thatit extends only between about 0.0020″ to 0.0030″ above the solder jointsbetween the communication cable 314 and the pressure sensing component306. However, larger and smaller thicknesses are utilized in otherimplementations. When applied at the subassembly level, the pottingmaterial 320 contacts the communication cable 314 (insulation andconductive wire), solder, sensor pads, pressure sensing component 306(silicon and glass portions in some instances). In that regard, in someembodiments the pressure sensing component 306 implements one or morefeatures of the pressure sensors disclosed in U.S. Pat. No. 7,967,762,which is hereby incorporated by reference in its entirety, including thetypes of materials and geometrical arrangements. When applied as part ofthe housing assembly, the potting material 320 further contacts one ormore of the core, sensor housing 302, solder, and other adhesives orpotting materials used in the assembly process.

Applicants have found that the use of potting materials havingparticular material characteristics over the connections between thecommunication cable 314 and the pressure sensing component 306 providean unexpectedly significant reduction and/or elimination of drift inpressure sensing intravascular device 300. To that end, the unexpectedresults associated with the particular potting materials of the presentdisclosure are discussed below with respect to FIGS. 7-14. In thatregard, in some embodiments the potting material 320 has a durometerhardness between about 20 Shore A and about 50 Shore A, with someparticular embodiments having a durometer hardness of approximately25-30 Shore A. Further, the potting material 320 has a moistureabsorption rate of about 0% per twenty-four hours in someimplementations. In some instances, the potting material 320 is aUV-cured potting material. The curing time is dependent upon the UVintensity output. In some instances, the UV output is optimized for acuring time between about 5 seconds and about 60 seconds, with someparticular embodiments having a curing time between about 15 seconds andabout 30 seconds. In that regard, in some embodiments, the UV-curedpotting material includes a secondary cure, such as a humidity cure or aheat cure. Further, the potting material 320 has a linear shrinkage of0% in some instances. In some implementations, the potting material 320has a coefficient of thermal expansion (m/m/-° C.) of between about1.0×10⁻⁵ and about 5.0×10⁻⁴, with some particular embodiments having acoefficient of thermal expansion (m/m/-° C.) of about 2.89×10⁻⁴. In someembodiments, the potting material 320 has a volume resistivity (Ω-cm)between about 6.0×10¹³ and about 1.0×10¹⁴, with some particularembodiments having a volume resistivity (Ω-cm) of about 8.3×10¹³. Insome implementations, the potting material 320 is Loctite® 5248™. Inthat regard, additional information about Loctite® 5248™ is available inthe Loctite® 5248™ Technical Data Sheet dated October 2004, which ishereby incorporated by reference in its entirety. In other instances,the adhesive 320 is selected from the group of adhesives consisting ofLoctite 5031-34 Shore A, Loctite 5040-30 Shore A, Loctite 5091-34 ShoreA, Loctite 5240-45 Shore A, and/or other suitable adhesives.

Then, with the potting material applied to the soldered electricalconnection and the pressure sensing component 306 positioned within thehousing 302, some of the spaces within the housing around the pressuresensing component 306, communications cable 314, core 316, and/or otherelements are filled with a potting material, adhesive, and/or coveredwith an encapsulant. For example, in the illustrated embodiment, anadhesive 318 is introduced between the housing 302 and the body of thepressure sensing component 306 adjacent to the opening 304. In someembodiments, the adhesive 318 is Dymax® Multi-Cure® 1128A-M Series GelAdhesive. In that regard, additional information about Dymax®Multi-Cure® 1128A-M Series Gel Adhesive is available in the Dymax®1128A-M Series Product Data Sheet dated Mar. 6, 2012, which is herebyincorporated by reference in its entirety. In other instances, theadhesive 318 is selected from the group of adhesives consisting ofLoctite 5031-34 Shore A, Loctite 5040-30 Shore A, Loctite 5091-34 ShoreA, Loctite 5240-45 Shore A, Loctite 5248-25 Shore A, Loctite 3211-51Shore D, and/or other suitable adhesives.

Further, as shown, an adhesive 322 is introduced within the proximalportion of the housing 302, within a distal portion of the flexibleelement 310, and around the communication cable 314 and core 316proximal of the pressure sensing component 306 to secure flexibleelement 310 to the housing 302. Generally, the adhesive 322 fills anygaps in the proximal portion of the housing 302 between the componentspositioned therein. In some embodiments, the adhesive 322 is Dymax®Multi-Cure® 1128A-M Series Adhesive. In that regard, additionalinformation about Dymax® Multi-Cure® 1128A-M Series Adhesive isavailable in the Dymax® 1128A-M Series Product Data Sheet dated Mar. 6,2012, which is hereby incorporated by reference in its entirety. A gelversion of the Dymax® 1128 adhesive is used in some instances because itcan be applied to a specific area and won't thin out prior to curing.Further, a low viscosity material is applied in some instances becauseit will wick into all of the threads of a coil (e.g., when flexibleelement 310 is implemented as a coil) and into the proximal end of thehousing. In some instances, the adhesive 322 is Loctite 4311-51 Shore Dor other suitable adhesive.

Referring more particularly to FIG. 6, shown therein are additionaldetails regarding the structural arrangement of the pressure sensingcomponent 306 and the interaction with potting material 320 according toan embodiment of the present disclosure. As shown, in the illustratedembodiment the pressure sensing component 306 includes a layer 324 thatis coupled to a layer 326. In that regard, in some instances layers 324and 326 are formed of different materials. For example, in someimplementations layer 324 is formed of silicon or other suitablesemiconductor substrate, while layer 326 is formed of glass. As shown, acavity or recess 328 formed in layer 326 is covered by the diaphragm308. Accordingly, in some instances the recess 328 acts as a referencepressure chamber for the diaphragm 308. As also shown, the pottingmaterial 320 covers the electrical coupling between the exposedconductors of the communication cable 314 and the electrical pads of thepressure sensing component 306. In that regard, the potting material 320adheres to and/or abuts to portions of layer 324 and layer 326. As aresult, expansion of the traditional potting materials having anincreased hardness relative to those of the present disclosure canimpart forces on layers 324 and 326 that result in undesirable varianceor drift in the pressure readings of the pressure sensing component 306.For example, in some instances the expansion of traditional pottingmaterials impart a shear stress between the layers 324 and 326 asindicated by arrows 330 and 332, which represent a directional forceimparted on the layers respectively. The potting materials 320 of thepresent disclosure substantially reduce and/or eliminate the forcesapplied to the layers 324 and 326 by having no linear shrinkage, lowerthermal expansion, and lower durometer hardness compared to traditionalpotting materials.

Referring now to FIGS. 7-14, shown therein are various graphsillustrating the extreme benefits of the embodiments of the presentdisclosure in terms of reducing and/or eliminating drift inpressure-sensing guide wires. Referring initially to FIG. 7, showntherein is a graph 350 illustrating average drift characteristics of anintravascular device using a potting material according to an embodimentof the present disclosure compared to average drift characteristics ofan intravascular devices using alternative potting materials indistilled water. The two bars on the left side of the graph 350illustrate the average absolute drift (mmHg) over one hour in distilledwater at a temperature of 37° C. for the intravascular device using apotting material according to an embodiment of the present disclosure,in particular Loctite® 5248™, while the two bars on the right side ofthe graph illustrate the average absolute drift (mmHg) over one hour indistilled water at a temperature of 37° C. for the intravascular deviceusing alternative potting materials, in particular Loctite® 4311™ andLoctite® 4013™. As shown, the average absolute drift (mmHg) for theintravascular device using a potting material according to an embodimentof the present disclosure is significantly less than the alternativepotting materials. In particular, the alternative potting materialsresult in a drift five to nine times as large as the potting materialsof the present disclosure, with the two runs of Loctite® 5248™ haveaverage drifts of 0.4 mmHg and 0.3 mmHg compared to 2.8 mmHg forLoctite® 4311™ and 1.9 mmHg for Loctite® 4013™.

Referring now to FIG. 8, shown therein is a graph 360 illustrating driftcharacteristics of an intravascular device using a potting materialaccording to an embodiment of the present disclosure compared to driftcharacteristics of intravascular devices using alternative pottingmaterials in saline. In that regard, line graph 362 illustrates thedrift (mmHg) over time in saline at a temperature of 37° C. for theintravascular device using a potting material according to an embodimentof the present disclosure, in particular Loctite® 5248™. Line graph 364illustrates the drift (mmHg) over time in saline at a temperature of 37°C. for the intravascular device using an alternative potting material,in particular Loctite® 4311™. Finally, line graph 366 illustrates thedrift (mmHg) over time in saline at a temperature of 37° C. for theintravascular device using another alternative potting material, inparticular Loctite® 4013™. As shown, whereas the line graphs 364 and 366associated with the alternative potting materials show significantdrift, including areas of shorting (i.e., complete failure of the wireto provide a useable signal), the line graph 362 associated with thepotting material according to the present disclosure has a steady plotwith limited drift.

Referring now to FIG. 9, shown therein is a graph 370 illustratingabsolute 1-hour drift characteristics of an intravascular device using apotting material according to an embodiment of the present disclosurecompared to absolute 1-hour drift characteristics of an intravasculardevice using an alternative potting material. The bar on the left sideof the graph 370 illustrates the average drift per hour (mmHg/h) indistilled water at a temperature of 37° C. for the intravascular deviceusing a potting material according to an embodiment of the presentdisclosure, in particular Loctite® 5248™, while the bar on the rightside of the graph illustrates the average drift per hour (mmHg/h) indistilled water at a temperature of 37° C. for the intravascular deviceusing an alternative potting material, in particular an Ablebond epoxythat is currently implemented in commercially available pressure-sensingguide wires. As shown, the average drift (mmHg/h) for the intravasculardevice using a potting material according to an embodiment of thepresent disclosure is significantly less than the currently used pottingmaterial. In particular, the currently used potting material results ina drift over ten times as large as the potting materials of the presentdisclosure, with the Loctite® 5248™ having an average drift of 0.79mmHg/h with a standard deviation of ±0.52 mmHg compared to the Ablebondepoxy having an average drift of 8.87 mmHg/h with a standard deviationof ±4.63 mmHg.

Referring now to FIG. 10, shown therein is a graph 380 illustratingabsolute initial offset characteristics of an intravascular device usinga potting material according to an embodiment of the present disclosurecompared to absolute initial offset characteristics of an intravasculardevice using an alternative potting material. The bar on the left sideof the graph 370 illustrates the initial offset (mmHg) in distilledwater at a temperature of 37° C. for the intravascular device using apotting material according to an embodiment of the present disclosure,in particular Loctite® 5248™, while the bar on the right side of thegraph illustrates the initial offset (mmHg) in distilled water at atemperature of 37° C. for the intravascular device using an alternativepotting material, in particular an Ablebond epoxy that is currentlyimplemented in commercially available pressure-sensing guide wires. Asshown, the initial offset (mmHg) for the intravascular device using apotting material according to an embodiment of the present disclosure issignificantly less than the currently used potting material and withless variation. In particular, the currently used potting material hasan initial offset over three times as large as the potting materials ofthe present disclosure, with the Loctite® 5248™ having an initial offsetof 0.48 mmHg/h with a standard deviation of ±0.74 mmHg compared to theAblebond epoxy having an initial offset of 1.60 mmHg with a standarddeviation of ±2.44 mmHg.

Referring now to FIG. 11, shown therein are a pair of graphs 390, 400illustrating the relative drift characteristics of an intravasculardevice using a potting material according to an embodiment of thepresent disclosure (graph 390) and an intravascular device using analternative potting material (graph 400). In that regard, graph 390illustrates the drift (mmHg) over time (min) in distilled water at atemperature of 37° C. for eight different intravascular devices withsensors implemented using a potting material according to an embodimentof the present disclosure, in particular Loctite® 5248™. On the otherhand, graph 400 illustrates the drift (mmHg) over time (min) indistilled water at a temperature of 37° C. for eight differentintravascular devices with sensors implemented using an alternativepotting material, in particular an Ablebond epoxy that is currentlyimplemented in commercially available pressure-sensing guide wires. Asshown, the drift of the intravascular device using a potting materialaccording to an embodiment of the present disclosure is significantlyless than the currently used potting material. Further, the drift of theintravascular device using a potting material according to an embodimentof the present disclosure has more consistency (i.e., less deviation)between runs relative to the currently used potting material.

Referring now to FIG. 12, shown therein is a graph 410 illustrating amaximum drift of an intravascular device using a potting materialaccording to an embodiment of the present disclosure compared to amaximum drift of an intravascular device using an alternative pottingmaterial in a twenty minute animal study. The bar on the left side ofthe graph 410 illustrates the maximum drift (mmHg) over twenty minutesin an animal study for the intravascular device using a potting materialaccording to an embodiment of the present disclosure, in particularLoctite® 5248™, while the bar on the right side of the graph illustratesthe maximum drift (mmHg) over twenty minutes in an animal study for theintravascular device using an alternative potting material, inparticular an Ablebond epoxy that is currently implemented incommercially available pressure-sensing guide wires. As shown, themaximum drift (mmHg) for the intravascular device using a pottingmaterial according to an embodiment of the present disclosure issignificantly less than the maximum drift of the currently used pottingmaterial. In particular, the currently used potting material results ina maximum drift over twenty times as large as the potting materials ofthe present disclosure in the twenty minute animal study, with theLoctite® 5248™ having an average maximum drift of 0.24 mmHg with astandard deviation of ±0.12 mmHg compared to the Ablebond epoxy havingan average maximum drift of 4.72 mmHg/h with a standard deviation of±0.47 mmHg.

Referring now to FIG. 13, shown therein is a graph 420 illustratingdrift characteristics of intravascular devices using a potting materialaccording to an embodiment of the present disclosure compared to driftcharacteristics of intravascular devices using an alternative pottingmaterial in a twenty minute animal study. In that regard, the three linegraphs identified as 422 illustrate the drift (mmHg) over time in ananimal study for the intravascular device using an alternative pottingmaterial, while the three line graphs identified as 424 illustrate thedrift (mmHg) over time in an animal study for the intravascular deviceusing a potting material according to an embodiment of the presentdisclosure, in particular Loctite® 5248™. Consistent with the previousgraphs, the intravascular device using a potting material according tothe present disclosure has a substantially overall drift and lessdeviation between runs.

Referring now to FIG. 14, shown therein is a graph 430 illustratingdrift characteristics of intravascular devices using a potting materialaccording to an embodiment of the present disclosure in a one houranimal study. In that regard, the graph 430 shows that even over a fullhour of in vivo use, the intravascular devices that use a pottingmaterial according to the present disclosure continue to have lowoverall drift with minimum deviation between wires and runs.

Persons skilled in the art will also recognize that the apparatus,systems, and methods described above can be modified in various ways.Accordingly, persons of ordinary skill in the art will appreciate thatthe embodiments encompassed by the present disclosure are not limited tothe particular exemplary embodiments described above. In that regard,although illustrative embodiments have been shown and described, a widerange of modification, change, and substitution is contemplated in theforegoing disclosure. It is understood that such variations may be madeto the foregoing without departing from the scope of the presentdisclosure. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the presentdisclosure.

What is claimed is:
 1. An intravascular sensing device, comprising: aflexible elongate body comprising a proximal portion, a distal portion,and a lumen extending along a length of the flexible elongate bodybetween the proximal and distal portions; a sensor housing disposed atthe distal portion of the flexible elongate body, wherein the sensorhousing comprises a proximal portion and a distal portion; a sensordisposed within the distal portion of the sensor housing; a plurality ofconductors electrically coupled to the sensor and extending from thesensor through the lumen to the proximal portion of the flexibleelongate body; a potting material within the distal portion of thesensor housing, the potting material covering electrical connectionsbetween the plurality of conductors and the sensor, the electricalconnections being at the distal portion of the sensor housing; and anadhesive within the proximal portion of the sensor housing, wherein theadhesive is in contact with the plurality of conductors at the proximalportion of the sensor housing.
 2. The intravascular sensing device ofclaim 1, wherein the sensor comprises a first layer and a second layer.3. The intravascular sensing device of claim 2, wherein the pottingmaterial abuts the first layer and the second layer of the sensor. 4.The intravascular sensing device of claim 2, wherein the first layercomprises silicon and wherein the second layer comprises glass.
 5. Theintravascular sensing device of claim 1, wherein the sensor comprises apressure sensor.
 6. The intravascular sensing device of claim 1, whereinthe potting material has a durometer hardness between about 20 Shore Aand about 50 Shore A.
 7. The intravascular sensing device of claim 1,wherein the potting material has a durometer hardness between about 25Shore A and about 30 Shore A.
 8. The intravascular sensing device ofclaim 1, wherein the potting material has a moisture absorption rate ofabout 0% per twenty-four hours.
 9. The intravascular sensing device ofclaim 1, wherein the potting material is a UV-cured potting material.10. The intravascular sensing device of claim 8, wherein the UV-curedpotting material includes a secondary humidity cure.
 11. Theintravascular sensing device of claim 1, wherein the potting materialhas a linear shrinkage of 0%.
 12. The intravascular sensing device ofclaim 1, wherein the potting material has a coefficient of thermalexpansion (m/m/-° C.) of between about 1.0×10⁻⁵ and about 5.0×10⁻⁴. 13.The intravascular sensing device of claim 11, wherein the pottingmaterial has a coefficient of thermal expansion (m/m/-° C.) of about2.89×10⁻⁴.
 14. The intravascular sensing device of claim 1, wherein thepotting material has a volume resistivity (Ω-cm) between about 6.0×10¹³and about 1.0×10¹⁴.
 15. The intravascular sensing device of claim 13,wherein the potting material has a volume resistivity (Ω-cm) of about8.3×10¹³.
 16. The intravascular sensing device of claim 1, furthercomprising: a first flexible element extending distally from the sensorhousing; and a second flexible element extending proximally from thesensor housing.
 17. The intravascular sensing device of claim 16,wherein at least one of the first or second flexible elements comprisesa coil.
 18. The intravascular sensing device of claim 16, wherein atleast one of the first or second flexible elements comprises a polymertubing.
 19. The intravascular sensing device of claim 1, wherein thesensor housing comprises a further lumen, wherein the potting materialpartially fills the further lumen at the distal portion of the sensorhousing, and wherein the adhesive completely fills the further lumen atthe proximal portion of the sensor housing.
 20. The intravascularsensing device of claim 1, further comprising a further adhesive incontact with the sensor and the sensor housing, the further adhesivelongitudinally overlapping the potting material at the distal portion ofthe sensor housing and the adhesive at the proximal portion of thesensor housing.